General Purpose Reagent
FDA product code PPM · Class I (low risk) · 21 CFR 864.4010 · Pathology
A general purpose reagent is a chemical reagent that has general laboratory application, that is used to collect, prepare, and examine specimens from the human body for diagnostic purposes, and that is not labeled or otherwise intended for a specific diagnostic application. It may be either an individual substance, or multiple substances reformulated, which, when combined with or used in conjunction with an appropriate analyte specific reagent (ASR) and other general purpose reagents, is part of a diagnostic test procedure or system constituting a finished in vitro diagnostic (IVD) test.
16510(k) clearances
0PMA approvals
30recalls
GMP exemptexempt from GMP rules
Manufacturers
- Richard-Allan Medical Ind., Inc. 3
- Omega Medical Diagnostics 2
- E K Ind., Inc. 2
- Volu Sol Medical Industries 1
- Interscience, Inc. 1
- Interscience Diagnostics, Inc. 1
- Anatech, Ltd. 1
- Roseville Medical Laboratoriesu 1
- Micro Media Laboratories 1
- Surgipath Medical Industries, Inc. 1
- Reagent Laboratory, Inc. 1
- Remel Co. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K871533 | Tomtec Gram Stainer DecolorizerPPM · Traditional | Remel Co. | 04/29/1987SE |
| K863550 | Potassium Hydroxide 10% W/VPPM · Traditional | Reagent Laboratory, Inc. | 10/02/1986SE |
| K861890 | 100%, 95%, 80% & 70% Dehydrant Custom Blend No. 2PPM · Traditional | Richard-Allan Medical Ind., Inc. | 06/03/1986SE |
| K850916 | SprayfixPPM · Traditional | Surgipath Medical Industries, Inc. | 03/25/1985SE |
| K850845 | 0.85% SalinePPM · Traditional | Micro Media Laboratories | 03/20/1985SE |
| K850737 | Transport Culture MediumPPM · Traditional | Roseville Medical Laboratoriesu | 03/20/1985SE |
| K842934 | Decolorizing Fluic, Acid-Alcohol 3%PPM · Traditional | E K Ind., Inc. | 09/12/1984SE |
| K842863 | Pro-Soft DehydrantPPM · Traditional | Anatech, Ltd. | 08/21/1984SE |
| K842729 | Decolorizing FluidPPM · Traditional | E K Ind., Inc. | 08/03/1984SE |
| K842070 | Idd DetergentPPM · Traditional | Interscience Diagnostics, Inc. | 07/02/1984SE |
| K831620 | Sodium Hypochlorite 3%PPM · Traditional | Omega Medical Diagnostics | 07/28/1983SE |
| K831619 | Sodium Hypochlorite 7%PPM · Traditional | Omega Medical Diagnostics | 07/28/1983SE |
| K822326 | Blended DETERGENT-78N 1912-1PPM · Traditional | Interscience, Inc. | 10/18/1982SE |
| K822037 | Volu-Sol Tap Water SubstitutePPM · Traditional | Volu Sol Medical Industries | 08/03/1982SE |
| K811800 | Bluing ReagentPPM · Traditional | Richard-Allan Medical Ind., Inc. | 08/12/1981SE |
| K811796 | Formal AlcoholPPM · Traditional | Richard-Allan Medical Ind., Inc. | 07/28/1981SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1984-2026 Class II | Immy, Myco DDR Trident, Bulk Neutralization Buffer B (60 X 30 mL), REF: TBPN67-60 For…Neutralization Buffer may contain contaminants | Immuno-Mycologics, Inc | 03/26/2026Open, Classified |
| Z-0773-2026 Class II | Akkermansia TestDistribution without premarket approval/clearance. | Get Tested International AB | 11/03/2025Open, Classified |
| Z-0943-2026 Class II | 1ml of DTT in liquid phase, in PET tube with capture cap, in bulkTreatment reagent functionality in respiratory specimens fluidification cannot be guaranteed. | Copan Italia | 10/29/2025Open, Classified |
| Z-0942-2026 Class II | 1ml of DTT in liquid phase, in PET tube with capture cap, in bulk + sputum transfer…Treatment reagent functionality in respiratory specimens liquification cannot be guaranteed. | Copan Italia | 10/29/2025Open, Classified |
| Z-1993-2025 Class II | STA - Owren Koller. Model/Catalog Number: 00360 STA - Owren-Koller is a buffer solution…Potential for shorter clotting times in clotting tests which have a dilution, leading to possible… | Diagnostica Stago, Inc. | 05/21/2025Open, Classified |
| Z-1834-2025 Class II | ORTHO CLINICAL DIAGNOSTICS INC FS(3PK/BX)ORCLNL DILUENT PACK 3.transit delays of certain cold chain products due to severe thunderstorms which may caused the products to… | Mckesson Medical-Surgical Inc. Corporate… | 04/24/2025Open, Classified |
| Z-0315-2025 Class II | intelliPATH Universal HRP Detection Kit, REF: IPK5011G80, containing DAB Buffer, Catalog…Kits containing the DAB chromogen buffer, intended for use in either manual or automated… | Biocare Medical, LLC | 09/25/2024Open, Classified |
| Z-2266-2024 Class II | VITROS Chemistry Products FS Diluent Pack 3, Model/Catalog Number: 6801754. Product…VITROS Chemistry Products FS Diluent Pack 3, Lot 01-1645 may cause results to be negatively biased when used… | Ortho-Clinical Diagnostics, Inc. | 05/21/2024Open, Classified |
| Z-1376-2024 Class II | Access Substrate, REF 81906, For use with the Access Immunoassay SystemsOn 07 February 2024 Beckman Coulter made the decision to conduct a field action on Access Substrate (81906)… | Beckman Coulter, Inc. | 02/07/2024Open, Classified |
| Z-2255-2023 Class II | NeuMoDx Cartridge-used for extraction, purification, amplification and detection of…Top label on some of the NeuMoDx cartridges within these lots may have been incorrectly applied during the… | NeuMoDx Molecular Inc | 05/24/2023Open, Classified |
| Z-1564-2022 Class II | NUCLISENS easyMAG Magnetic Silica, REF 280133, 24 x 1.2mL bottles/kit.There is a potential of no result leading to possible delayed result due to contamination of extraction… | bioMerieux, Inc. | 07/20/2022Open, Classified |
| Z-1384-2022 Class III | Kit Label: Anti-FITC-AP CISH Accessory Kit (Dako Omnis), Box A REF K589911-2…Label provided for substrate vail contained incorrect expiration date. | Agilent Technologies, Inc. | 05/20/2022Open, Classified |
| Z-0824-2022 Class III | Cytocell 8 Square Template Slides (Glass)- microscope slides Reference: PCN008Labelled with an incorrect expiry date on the outer label with an extended expiry date than the validated… | Cytocell Ltd. | 02/14/2022Terminated |
| Z-0503-2022 Class II | VITROS Immunodiagnostic Products High Sample Diluent A Reagent PackLower than expected results for VITROS Immunodiagnostic Products TSH Reagent Pack when diluted with VITROS… | Ortho-Clinical Diagnostics, Inc. | 11/22/2021Open, Classified |
| Z-3004-2020 Class III | PrepIT Q2A Kit, Model PT-Q2A-96 containing component reagent AG (PT-QAG-96) 1.4mL and ST…Reagents were shipped to customers after the Use by data indicated on its labeling. | DNA Genotek Inc. | 06/24/2020Terminated |
| Z-1365-2020 Class II | NUCLISENS Lysis Buffer, IVD, REF 200292, 48X2 ML LYS Manufacturer bioMerieux SA 376…Following a customer complaint about colored eluates, leading to invalid results bioMerieux has confirmed an… | BIOMERIEUX - Grenoble | 01/10/2020Terminated |
| Z-0443-2019 Class II | bioMrieux NucliSENS easyMAG Lysis Buffer ref. 280134Some eluates become colored because of remaining hemoglobin in the eluate. | bioMerieux, Inc. | 10/08/2018Terminated |
| Z-0218-2019 Class II | NucliSENS Magnetic Extraction ReagentsData loggers showed that one shipment to the United States experienced low temperatures that may impact… | BioMerieux SA | 09/17/2018Terminated |
| Z-3016-2018 Class I | ultraView SISH DNP Detection Kit, Catalog Number 05907136001, model 800-098…Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC… | Ventana Medical Systems Inc | 08/02/2018Terminated |
| Z-3008-2018 Class I | VENTANA ISH iView Blue Detection Kit, Catalog Number 05278511001, model 800-092…Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers | Ventana Medical Systems Inc | 08/02/2018Terminated |
| Z-3002-2018 Class I | ISH iVIEW Blue Plus Detection Kit, Catalog Number 05266181001, model 760-097…Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC… | Ventana Medical Systems Inc | 08/02/2018Terminated |
| Z-1545-2018 Class III | BD MAX DNA MMK Lab Use, catalog no. 442828The package insert incorrectly lists the volume of the primer and probe diluent to use for the… | Becton Dickinson & Co. | 03/02/2018Terminated |
| Z-1544-2018 Class III | BD MAX DNA MMK (SPC) For Laboratory Use, catalog no. 442829The package insert incorrectly lists the volume of the primer and probe diluent to use for the… | Becton Dickinson & Co. | 03/02/2018Terminated |
| Z-0739-2018 Class I | ultraView SISH DNP Detection Kit, Ventana Part Number 800-098, Roche GMMI 05907136001 in…Increased reports of leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers… | Ventana Medical Systems Inc | 12/19/2017Terminated |
| Z-0733-2018 Class I | ultraView SISH DNP Detection Kit US, Ventana Part Number 760-098, Roche GMMI 05572037001…Increased reports of leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers… | Ventana Medical Systems Inc | 12/19/2017Terminated |
| Z-0732-2018 Class I | ultraView SISH Detection Kit, Ventana Part Number 780-001, Roche GMMI 05271967001 in…Increased reports of leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers… | Ventana Medical Systems Inc | 12/19/2017Terminated |
| Z-0086-2018 Class II | NucliSENS Lysis Buffer Extended lot for RES 76675Elute may become colored due to the residual presence of heme group origination from hemoglobin present in… | BioMerieux SA | 10/18/2017Terminated |
| Z-1713-2017 Class II | NucliSENS Lysis Buffer, REF 200292 NucliSENS Lysis Buffer is intended to be use for the…Problem with colored eluates for whole blood extractions | BioMerieux SA | 03/07/2017Terminated |
| Z-0977-2017 Class I | NucliSENS magnetic extraction reagents, For in vitro diagnostic use, Product Usage:…A drift of the performance with the BK test (BK virus, worst case application) was observed for some silica… | BioMerieux SA | 11/23/2016Terminated |
| Z-0976-2017 Class I | MagSIL (NucliSENS easyMAG Magnetic Silica), Product Usage: The NucliSENS easyMAG system…A drift of the performance with the BK test (BK virus, worst case application) was observed for some silica… | BioMerieux SA | 11/23/2016Terminated |